The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

Dova Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Onychomycosis

Treatments: Drug: Vehicle; Drug: IDP-108

Study type: Interventional

Funder types: Industry

Identifiers

NCT01007708

DPSI-IDP-108-P3-02

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.

Enrollment: 780 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically diagnosed onychomycosis of the target nail
• Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
• Has a positive KOH examination from the target nail
• Has a positive dermatophyte culture from the target nail

Exclusion criteria

• Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
• Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
• Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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780 participants in 2 patient groups, including a placebo group

IDP-108

Experimental group

Treatment:

Drug: IDP-108

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle